Validation Protocol and Report Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Validation Protocol and Report Procedure governs the structure and content of all validation protocols and reports (IQ, OQ, PQ and PPQ) made part of product development and process validation.

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ISO 13485:2016 Protocol and Report Procedure

The Validation Protocol and Report Procedure governs the structure and content of protocols and reports related to equipment, process and product.

ISO 13485:2016 Protocols and Reports Procedure Overview

The Validation Protocol and Report Procedure instructs on the development of Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Performance Qualification (PQ) Protocols and Product Performance Qualification (PPQ) Protocols. The Validation Protocol and Report Procedure also provides instruction on the format and required content of all validation final reports.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.